K242778 is an FDA 510(k) clearance for the X Sensor (Model: IOS-A15IF, HDI-15DGF). This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Qpix Solutions, Inc. (Morrisville, US). The FDA issued a Cleared decision on October 11, 2024, 28 days after receiving the submission on September 13, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K242778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2024 |
| Decision Date | October 11, 2024 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUH - System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |